Cell Processing Team Lead - GMP Manufacturing (Onsite)

ProKidney Corp.; Winston-Salem (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC seeks a Team Lead, Cell Processing to oversee aseptic cell manufacturing, ensure cGMP compliance, and drive continuous improvement. You will mentor staff, lead CAPA investigations, and ensure GMP documentation is accurate and complete.

The role is onsite with a Sunday-Thursday schedule 7:00 a.m. to 3:30 p.m., with overtime as needed. You will collaborate cross-functionally to optimize operations and maintain a safe, compliant cleanroom environment.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry or related field; a science discipline preferred.
• 4–6 years of relevant cell processing or biotech manufacturing experience in a cGMP environment.
• Strong knowledge of cell culture techniques and GMP documentation.

Responsibilities

• Lead day-to-day operations of the manufacturing team to ensure efficient processes.
• Initiate deviations, CAPAs, and CCRs; lead investigations with data support.
• Serve as SME on manufacturing processes and provide guidance and training.
• Troubleshoot manufacturing issues and direct corrective actions.
• Review batch records for GMP compliance and assist SOP development.
• Participate in aseptic processing in a cleanroom per cGMPs.
• Work with ERP for production tracking and BOM management.
• Assist in hiring, training, and mentoring new staff.
• Maintain GMP documentation and GDP compliance.
• Support cleanroom maintenance and safety adherence.

Skills

Cell processing

cGMP knowledge

Troubleshooting

Documentation

Problem solving

Education

AS/BS in Biotechnology/Biology/Chemistry

Tools

Excel

ERP system

MS Office

Job description

ProKidney Corp. in Winston-Salem, NC seeks a Team Lead, Cell Processing to oversee aseptic cell manufacturing, ensure cGMP compliance, and drive continuous improvement. You will mentor staff, lead CAPA investigations, and ensure GMP documentation is accurate and complete.

The role is onsite with a Sunday-Thursday schedule 7:00 a.m. to 3:30 p.m., with overtime as needed. You will collaborate cross-functionally to optimize operations and maintain a safe, compliant cleanroom environment.